Professional Documents
Culture Documents
Effective Contamination Control, Cleanroom Protocols, & Lab Safety
Effective Contamination Control, Cleanroom Protocols, & Lab Safety
dbryant@lci.kent.edu, 330-672-1583
bentley_wall@yahoo.com, 330-672-1525
External Resources
• **Cleanroom Technology: Fundamentals of Design, Testing, &
Operation, W. Whyte, Wiley & Sons, 2001, ISBN 0 471 86842 6
• **Introduction to Contamination Control & Cleanroom Technology,
Matts Ramstorp, Wiley-VCH, 2000, ISBN 3-527-30142-9
• Encyclopedia of Cleanrooms, Bio-Cleanrooms, and Aseptic Areas,
Philip Austin, CRC Press, 2000, ISBN 0970113501
• Cleanroom Microbiology for the Non-microbiologist, David Carlberg,
1995, CRC Press, ISBN 0935184732 (2nd edition due Oct 2004)
• Cleanroom Design, W. Whyte, Wiley & Sons, 1999, ISBN
0471942049
• Trade Publications:
– Cleanrooms Magazine, http://www.cleanrooms.com/
– A2C2 Magazine, http://www.a2c2.com/
• **=source for many of images in presentation
Outline
• Introduction—Cleanroom definitions
• Facility design & layout principles
• Air flow
• Contamination & Measurement
• Cleaning & Materials Selection
• The user!!
• Protocols to improve control
• Safety Practices
• Conclusions
Things to Remember
• It is important for users to understand
concepts behind clean processing
• Benefit from the experiences of others
(standards, anecdotal information)
• Impact that a single user can have on
overall process yield can be huge!
Historical Perspective
• Why Cleanrooms?
– First cleanrooms were in hospitals to prevent disease transmission
and infection in operating rooms (over 100 years ago!)
– Valuable tool to prevent particulate and bio contamination
– Most well known use is in semiconductor industry, but also
essential in pharmaceuticals, flat panel displays, space program,
photonics, life sciences, industrial (painting, assembly), etc.
– Essential for LCDs because of coating processes, small cell gaps
– Cleanroom itself is only part of the solution
Methods to Achieve Cleanliness
• Positive Pressure / Airflow
– Keeps contamination out of the work area
– Depends on clean air input
• Filtration
– Development of effective filtration revolutionized industry
– HEPA (High Efficiency Particulate Air) and ULPA (Ultra Low Particulate
Air) Filters
• Materials Selection
• User Protocols
• Cleaning
• All are very important!
Definition of Clean Room / Area I
• In US, classes still referred to as defined by
Federal Standard 209D
Definition of Clean Room / Area II
• Now superseded by ISO 14644-1; particles measured per
cubic meter
Definition of Clean Room / Area III
• Conversion between standards:
Outline revisited
• Introduction—Cleanroom definitions
• Facility design & layout principles
• Air flow
• Contamination
• Measurement
• The user!!
• Protocols to improve control
Facility Design
• Complete cleanroom created with
centralized air handling or fan filter units
• Keeps entire room clean
• Requires complete gowning, careful
materials and equipment selection to
maintain class
• Costly, often unnecessary
Facility Design
• Can use localized clean areas
• Clean Benches: Horizontal and Vertical Laminar
Flow (HLF on left, VLF on right)
Facility design
• Isolators, Glove boxes provide better
protection from outside contamination
Contamination Control by Layout
• Isolation between
processes prevents
cross contamination;
separate rooms, air
showers, door
interlocks
• “Onion” concept:
cleanest areas are
inside, have to pass
through successively
cleaner areas to
reach these areas
Outline
• Introduction—Cleanroom definitions
• Facility design & layout principles
• Air flow
• Contamination & Measurement
• Cleaning & Materials Selection
• The user!!
• Protocols to improve control
Air Flow & Turbulence
• Most airflow is
turbulent—no clear
relation between
velocity vectors at
different points
Invisible to naked
eye below ~50um
without special
illumination
Particulate Contamination
• Biggest concern for LCI cleanroom users
• Basis for classification of cleanrooms
• Does include biological contamination as a
subset of total particulates
• Many sources: personnel, equipment, etc.
Problem of Aerosols
• Generic term for particles that tend to
remain airborne
• Small size of particles means that gravity
has lesser effect; think cigarette smoke
• Can remain in turbulent eddy currents for
long periods, not removed from room
Microbial Contamination
• Outer layer of human skin can host up to 1
million microorganisms per square cm
• Human saliva up to 1 billion per mL
• Bacteria is usually primary concern, but
foreign organic matter, viruses, fungi, algae
are all included here
• Cross contamination can be a big issue!!
Contamination Measurement
• Particulate contamination typically
measured with laser particle counter
• Microbial contamination can be measured
in several ways
– Centrifugal sampler
– Settle plate method
– Contact plate method
– Swabbing
How to Use Measurements
• Complementary to yield tracking
• Can use measurements to isolate problem areas
• Regular measurements can help to track changes,
which can then be tied back to protocol, personnel,
or material changes
– Don’t depend upon room to maintain itself; verify!
• Possible to isolate culture lines responsible?
Reality
• In a perfect world, could monitor many
points on a very regular basis
• In reality, this is usually not practical, due
to personnel time and financial constraints
• Important to identify a realistic test &
measurement program
Outline
• Introduction—Cleanroom definitions
• Facility design & layout principles
• Air flow
• Contamination & Measurement
• Cleaning & Materials Selection
• The user!!
• Protocols to improve control
Contamination Control and Its
Relationships
• All sources of contamination and control are interrelated
Cleaning
• Critical to remove contaminants that cannot
be removed by air handling
• Important to follow procedures appropriate
to your application
• What is appropriate for one industry may
not be appropriate for another
• Most important thing is to develop standard
procedures and FOLLOW THEM
Surfaces are important
• The efficiency of these cleaning methods
depends on the surface being cleaned
• Rough or pitted surfaces are more difficult
to clean
• Sharp corners are difficult to clean
• Why are inside surfaces of cleanrooms
smooth?
Vacuuming
• Dry and wet
– Dry has low (<25% ) efficiency for particles
smaller than 10 microns (about .0005 inches)
– wet uses liquids which result in greater force on
the particles and hence better cleaning
Wet wiping
• Can be very efficient
• Liquid breaks some bonds between surface
and particles and allows particles to float off
• Those adhering on surface can be rubbed off
and retained in wiper.
• Must be careful not to redeposit particles
• Efficiency varies
Tacky rollers
• Efficiency depends of tackiness of roller,
cleanliness of tacky surface and softness of
roller are also very important
Cleaning liquids
• No ideal cleaning liquid
• Most facilities use DI water or isopropyl
alcohol with disinfectant
• Water with surfactant and disinfectant may
be used as well as alcohol-water solutions
• The choice depends on what works, cost,
history, etc.
Materials Selection
• Choice of materials for supplies, equipment,
gowning, etc. is important
• “Clean” materials can become dirty!!
• Look for easy-to-clean materials
• Triboelectricity can cause static problems,
as can low humidity—this exacerbates
contamination problems
• Biofilms!!
Outline
• Introduction—Cleanroom definitions
• Facility design & layout principles
• Air flow
• Contamination & Measurement
• Cleaning & Materials Selection
• The user!!
• Protocols to improve control
• Conclusions
Impact of the Cleanroom User
• Truth: Manufacturers can achieve similar
yield results using cost effective flow hoods
and isolation chambers as with full-blown
central cleanrooms
• BUT: user behavior is much more critical in
these areas!!!
Gowning at the LCI, I
• Put on plastic shoe covers (booties) over your
shoes in the hallway
• If you wear boots or other heavy contaminating
shoes, consider keeping a pair of sneakers in your
office for use in the cleanroom
• Open door and enter cleanroom
• Log in on computer at entrance
• Put on gowning gloves
Gowning at the LCI, II
• Put on hairnet
• If using Class 10K south only, put on lab smock
and proceed to usage area
• If using main cleanroom, proceed to
gowning room
• Pick up an appropriately sized head cover
and put on
• If previously in cleanroom, can use garment
stored on hanger
Gowning at the LCI, III
• Pick up an appropriately sized coverall and put on,
being careful to avoid allowing coverall to touch
floor
• Tuck head cover into coverall before zipping up
coverall
• Pick up an appropriately sized set of shoe covers
and put on over plastic booties and coverall; snap
shoe cover to back of pant leg and pull tight
• Put on second set of gloves, being careful to pull
glove over cuff of coverall
• Put on safety glasses and proceed to air shower
Common Protocol Violations
• Not wearing Safety Glasses
• Improper gowning
– zippers, snaps, masks
• Non-cleanroom materials in cleanroom
– paper, cardboard, personnel items
• Not cleaning up after you are finished
• General conduct
– Fast motions, incorrect carrying of materials
– Remember laminar flow; minimize turbulence
Effect of the Cleanroom User
Activity and Particle Generation